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Helps medical device and IVD teams review EU MDR and IVDR compliance requirements.
Copy the install command and let the AI configure it · recommended for beginners
Please install the "io.github.CSOAI-ORG/mdr-medical-device-mcp" MCP server from askskill: Run: claude mcp add 'io-github-csoai-org-mdr-medical-device-mcp' -- npx -y mdr-medical-device-mcp
Based on EU MDR 2017/745, summarize the main compliance requirements for a Class IIa medical device regarding technical documentation, clinical evaluation, and post-market surveillance.
A topic-based summary of compliance requirements for quickly identifying key obligations.
Using EU IVDR 2017/746, create a pre-market compliance checklist for an in vitro diagnostic product covering performance evaluation, labeling and IFU, quality management, and registration requirements.
A structured checklist listing key documents, processes, and readiness items.
Compare the main differences between EU MDR and IVDR in scope, classification rules, technical documentation, and post-market requirements, and present them in a table.
A clear comparison table to help teams distinguish between the two regulatory frameworks.
Retrieve verbatim EU compliance regulations and pinpoint relevant legal provisions fast.
Helps teams check EU AI Act requirements and compliance guidance.
Assess EU CRA compliance for AI agents and classify products correctly.
Check EU Mobility Package compliance for drivers' hours and return obligations.
Classify product digital elements into the EU Cyber Resilience Act hierarchy.
Helps map FDA AI/ML SaMD pathways for 510(k), PMA, and De Novo.